1. Technical Field
The present invention is generally directed to the field of biomedical information analysis, and more particularly to computer methods and systems of accessing biomedical information.
2. Description of the Related Art
Biomedical research data that describe, measure and improve life is becoming the vital exchange medium for all new medical knowledge and the way by which we understand it. However, a resulting culture of point-solution software and services acquisitions, combined with large systems integrators, has created an inefficient tapestry of non-standardized data technology systems with high ongoing maintenance and support costs.
The number of transfers a therapy undergoes during development exacerbates this state of affairs. For instance, many drug compounds are sold or licensed at multiple times. This does not include the myriad exchanges of data and information between the sponsor and its external partners, such as laboratories, independent data review boards and regulatory authorities. As a result, nearly all strategic plans for the world's largest pharmaceutical research firms include provisions for reengineering the data access and analysis model.
The Food and Drug Administration (FDA) is the primary agency of the United States government that oversees the approval process of therapeutic compounds. The FDA requires as part of the approval process meticulous records that allow the agency to review all data generated for a particular compound.